Fastum gel 2.5% tube 50 g

active substance: ketoprofen;

1 g of gel contains 0.025 g of ketoprofen;

auxiliary substances : carbomer, ethanol 96%, neroli flavor (contains citral, citronellol, farnesol, geraniol, D-limonene and linalool), lavandin flavor (contains coumarin, geraniol, D-limonene and linalool), triethanolamine, purified water.

Gel.

The main physical and chemical properties: a gel of a mucous consistency, colorless or almost transparent, with an aromatic smell.

Nonsteroidal anti-inflammatory drugs for local use. ATX code M02A A10.

Pharmacodynamics.

Ketoprofen has an anti-inflammatory and analgesic effect.

Ketoprofen, contained in the appropriate filler, reaches the inflammation zone through the skin and thus provides the possibility of local treatment of joint, tendon, ligament and muscle lesions accompanied by pain syndrome.

Pharmacokinetics.

Absorption of the medicinal product applied to the skin into the general bloodstream is very slow. When applying from 50 to 150 mg of ketoprofen, the concentration of the active substance in the blood plasma after 5–8 hours is only 0.08–0.15 μg/ml.

Post-traumatic pain in muscles and joints, inflammation of tendons.

FASTUM ^® GEL is contraindicated in the following cases:

• Hypersensitivity to the active substance or to any of the excipients.
• History of hypersensitivity.
• History of photosensitivity reaction.
• Hypersensitivity reactions, such as asthma symptoms, allergic rhinitis and urticaria, have been reported with ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• The presence in the anamnesis of skin manifestations of allergy when using ketoprofen, tiaprofenic acid, fenofibrate, UV blockers or other perfumed products.
• Exposure to sunlight, even in the form of diffused light or UV radiation in a tanning bed, during treatment and for two weeks after its termination (see section “Particulars of use”).
• Application to skin with pathological changes, such as dermatosis, eczema or acne, to infected skin or to open wounds.
• Application to the skin around the eyes.
• The third trimester of pregnancy (see the section “Use during pregnancy or breastfeeding”).

No interactions of FASTUM GEL with other medicinal products were observed. Interaction is unlikely, since the concentration in the serum after topical application is low. Nevertheless, it is recommended to monitor the condition of patients receiving treatment with coumarin derivatives.

FASTUM GEL should be used with caution in patients with heart, liver or kidney failure. There have been reports of isolated cases of systemic adverse reactions associated with kidney damage.

The use of the gel should not be combined with wearing an occlusive bandage.

The gel should not come into contact with mucous membranes and eyes.

Local use of a large amount of the drug can lead to such systemic effects as, for example, hypersensitivity and bronchial asthma.

The use, especially for a long time, of drugs for local use can cause phenomena of sensitization or local irritation.

In case of redness, the treatment should be stopped.

In the event of the development of any skin reactions, including those related to the concomitant use of products containing octocrylene, treatment with the gel should be stopped immediately (octocrylene is an auxiliary substance used to prevent photodegradation of cosmetics and personal care products, such as shampoos, aftershave lotions, shower and bath gels, skin creams, lipstick, anti-aging creams, make-up removers and hair sprays).

During treatment and for 2 weeks after its completion, it is recommended to wear clothing that covers the application area to avoid photosensitivity.

Hands should be thoroughly washed after each application of the medicinal product. The recommended duration of treatment should not be exceeded, as the risk of developing contact dermatitis and photosensitivity reactions increases over time.

Patients who have asthma in combination with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of allergy to aspirin and/or nonsteroidal anti-inflammatory drugs than the general population.

Addiction to the drug FASTUM GEL does not develop.

Pediatric patients: safety and efficacy of ketoprofen gel in children have not been established.

FASTUM GEL contains neroli flavoring, which includes such allergens as citral, citronellol, farnesol, geraniol, D-limonene and linalool, as well as lavandin flavoring, which in turn contains such allergens as coumarin, geraniol, D-limonene and linalool. These allergens can cause allergic reactions.

FASTUM GEL contains ethanol, which can cause a burning sensation on the affected skin.

Use during pregnancy or breastfeeding.

There are no clinical data on the dosage form for local use. The following recommendations are based on data related to dosage forms for systemic use.

Pregnancy.

There are no clinical data on the use of medicinal forms of ketoprofen for local use during pregnancy. Even if the systemic exposure is lower compared to oral administration, it is not known whether the systemic exposure of ketoprofen achieved after topical application can be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, FASTUM ^® GEL should not be used unless absolutely necessary. If used, the dose should be as low as possible, and the duration of treatment should be as short as possible.

During the third trimester of pregnancy, systemic use of prostaglandin synthesis inhibitors, including ketoprofen, can cause toxic damage to the heart, lungs, and kidneys of the fetus. At the end of pregnancy, both the mother and the child may experience prolonged bleeding, as well as delayed delivery. Therefore, FASTUM GEL is contraindicated during the last trimester of pregnancy (see section “Contraindications”).

The use of NSAIDs can also cause a delay in childbirth.

Breast-feeding.

There are no data on the penetration of ketoprofen into mother’s milk when it is applied topically. After systemic use, traces of ketoprofen were detected in mother’s milk. The use of ketoprofen by mothers who are breastfeeding is not recommended.

During the first and second trimesters of pregnancy and during breastfeeding, the drug FASTUM GEL should be used only after consultation with a doctor and after a joint assessment of the benefit/risk ratio in each individual case. If you are likely or planning to become pregnant, consult your doctor before using this medication.

The ability to influence the speed of reaction when driving vehicles or other mechanisms.

It is unknown.

The gel should be applied in a thin layer (3–5 cm) to the affected areas from 1 to 3 times a day, and for better penetration, use light massage movements.

Special precautions for disposal and other handling.

Opening the soft aluminum tube : unscrew the cap and pierce the aluminum membrane with the tip located on the outer part of the cap.

Children.

The safety and effectiveness of ketoprofen gel for children have not been established.

With local application, overdose is unlikely. Taking into account the low level of ketoprofen in blood plasma when applied to the skin, overdose phenomena can be excluded. If the gel is accidentally swallowed, systemic side effects may develop, the severity of which depends on the amount of the drug swallowed. In these cases, symptomatic and supportive treatment should be carried out, as in the case of an overdose of anti-inflammatory drugs used internally.

Like all medicines, FASTUM GEL can cause side effects, although not everyone develops them.

As with other medicinal products for topical use, unwanted effects may occur on the skin. There have been reports of local skin reactions (e.g. erythema, pruritus, and burning), which may spread beyond the application site and in some cases may be severe and generalized (e.g., bullous or phlyctenular eczema), in addition to hypersensitivity reactions. and skin reactions (photosensitivity).

The frequency and severity of these effects are greatly reduced by avoiding exposure to sunlight, including tanning beds, during treatment and for two weeks after treatment.

Other systemic effects of NSAIDs: their development depends on the transdermal diffusion of the active substance and, thus, on the amount of gel applied, the area of ​​damage, the degree of skin integrity, the duration of treatment and the use of occlusive dressings (reactions from the digestive system and kidneys).

When analyzing unwanted effects, the frequency of adverse reactions was determined as follows: very often (≥ 10%), often (≥ 1/100, < 1/10), sometimes (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), unknown (on the basis of the available data, the frequency cannot be estimated).

Immune system disorders

Not known: anaphylactic reactions, including anaphylactic shock, angioedema, hypersensitivity reactions.

Disturbances from the gastrointestinal tract

Very rarely: peptic ulcer, gastrointestinal bleeding, diarrhea.

Disorders of the skin and subcutaneous fat

Sometimes: local skin reactions such as erythema, eczema, itching and burning sensation.

Rarely: dermatological reactions (photosensitization, bullous rashes and urticaria). Severe adverse reactions, such as bullous or phlyctenular eczema, which can spread or become generalized, develop extremely rarely.

Very rare: contact dermatitis.

Not known: bullous dermatitis.

Disorders of the kidneys and urinary tract

Very rare: renal failure or deterioration if present. Isolated cases of systemic adverse reactions, such as renal impairment, have been reported.

Elderly patients are especially prone to the development of adverse reactions to NSAIDs.

Notification of possible adverse reactions

Post-marketing adverse reaction reporting is very important. They allow you to continue monitoring the benefit-risk ratio when using the drug. Healthcare workers are asked to report any suspected adverse reactions.

5 years

Do not use the medicine after the expiration date indicated on the package.

No special storage conditions are required. Keep out of the reach of children.

A tube containing 20 g or 30 g or 50 g or 100 g of gel; 1 tube in a cardboard box.